U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761484
Company: JANSSEN BIOTECH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE 1,600MG/20,000 UNITS PER 10ML VIAL; SINGLE-USE Prescription None No No
RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE 2,240MG/28,000 UNITS PER 14ML VIAL; SINGLE-USE Prescription None No No
RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE 2,400MG/30,000 UNITS PER 15ML VIAL; SINGLE-USE Prescription None No No
RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE 3,5200MG/44,000 UNITS PER 22ML VIAL; SINGLE-USE Prescription None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/2026 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761484Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761484Orig1s000correctedltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/13/2026 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761484Orig1s000correctedlbl.pdf
Back to Top